Drug FDA Class II Terminated cGMP deviation

THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 01056 6), Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031

Unexo Life Sciences Private Limited Published Dec 4, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Unexo Life Sciences Private Limited or your place of purchase with questions, and see the source record below for full details.

Reason for recall

cGMP Deviations

Affected products (1)

THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 01056 6), Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031

THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH · 455,536 patches

NDC: 71101-001, 71101-001-06, 71101-001-24

Code info: a) UPC 8 45717 00878 5 b) UPC 8 45717 01056 6

Affected areas

Nationwide

Timeline

Initiated

Oct 24, 2024
Published

Dec 4, 2024
Terminated

Sep 16, 2025

Recall number: D-0065-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.